Ophthalmic Clinical Trials Associate II

Ora; United States; Remote; USD 55,000 - 75,000; Full time

Job summary

Ora is seeking a Clinical Trial Associate II to support project managers in ophthalmic clinical studies. You will assist in site management, regulatory document collection, and study documentation in alignment with GCP/ICH standards.

You will help develop essential study documents, maintain trial master files, and support planning and tracking activities. Strong communication and organization are required for success.

Qualifications

• Bachelor’s degree and a minimum of 1-year experience in clinical trials.
• Ophthalmic experience strongly preferred.
• Knowledge of GCP/ICH regulations.
• Experience maintaining electronic trial master files.
• Excellent verbal and written communication and organizational skills.

Responsibilities

• Ensure study documentation, communication, training and data collection aligns with study protocol, SOPs, regulations.
• Lead development of assigned study-related documents (e.g., informed consent, source documents, study logs).
• Participate in all phases of clinical trial site management from start-up to close-out.

Skills

Ophthalmic experience

GCP/ICH regulations

Regulatory document management

Electronic TMF

Communication skills

Time management

Education

Bachelor’s degree

Tools

Box.com

eTMF systems

Job description

Ora is seeking a Clinical Trial Associate II to support project managers in ophthalmic clinical studies. You will assist in site management, regulatory document collection, and study documentation in alignment with GCP/ICH standards.

You will help develop essential study documents, maintain trial master files, and support planning and tracking activities. Strong communication and organization are required for success.